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Protocol Details

Concurrent fMRI-guided rTMS and Cognitive Therapy for the Treatment of Major Depressive Episodes

This study is currently recruiting participants.

Summary | Eligibility | Citations | Contacts

Summary

Number

17-M-0147

Sponsoring Institute

National Institute of Mental Health (NIMH)

Recruitment Detail

Type: Participants currently recruited/enrolled
Gender: Male & Female
Min Age: 18 Years
Max Age: 65 Years

Referral Letter Required

No

Population Exclusion(s)

Adults who are or may become unable to consent;
Pregnant Women;
Non-English Speaking;
Children

Keywords

Transcranial Magnetic Stimulation (TMS);
Major Depressive Disorder;
Cognitive Therapy

Recruitment Keyword(s)

None

Condition(s)

Major Depressive Disorder

Investigational Drug(s)

None

Investigational Device(s)

None

Intervention(s)

Other: Sham TMS + Cognitive therapy
Other: Active TMS + Cognitive therapy

Supporting Site

National Institute of Mental Health

Background:

Repetitive transcranial magnetic stimulation (rTMS) is a treatment for depression. It stimulates the brain. Researchers want to see if using magnetic resonance imaging (MRI) scans helps locate the best area for rTMS in each person. They also want to find other ways to make it more effective.

Objective:

To study the effects of combining MRI- guided transcranial magnetic stimulation (TMS) and talk therapy on the brain in people with depression.

Eligibility:

Adults ages 18-65 with a major depressive disorder and current depression. If taking an antidepressant, should have been doing so for at least 4 weeks.

Design:

Participants will be screened with medical and psychiatric history, psychiatric evaluation, physical exam, and blood and urine tests.

Phase 1 is 1-4 visits in 1 week. Participants will have:

-Brain MRI. Participants will lie on a table in a scanner.

-Questions about their medical history and psychology symptoms

-Tests of mood and thinking

-Tests of brain activity. Participants may do tasks during these tests:

-- A cone with magnetic detectors is put on the head.

-- A cap with electrodes is put on the scalp.

-- TMS. A brief electrical current passes through a wire coil on the scalp.

-- A metal disk will be placed on the arm. A nerve will be stimulated with a small electrical shock.

Phase 2 is about 6 to 7 weeks.

-There will be 30 daily sessions of combined therapy and repetitive TMS (rTMS) for 6 weeks.

-Participants will receive rTMS and another therapy by computer.

-For rTMS, repeated pulses will pass through the coil.

-This is followed by up to 3 additional visits, when:

-- Participants will repeat Phase 1 tests

-Participants will rate their depression symptoms.

Phase 3 is 3 visits over 3 months. Participants will rate their depression symptoms and repeat some of the previous questionnaires and tests of mood and thinking.

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Eligibility

INCLUSION CRITERIA:

- 18 to 65 years of age.

- Use of effective method of birth control for women able to become pregnant

- Native English language speaker

- Major Depressive Episode Diagnosis, Severity, and Duration:

-- Subjects will meet the DSM-IV-TR primary diagnosis of initial or recurrent Major Depressive Disorder by DSM-IV-TR criteria -- HAM-D score greater than 17 and Item 1 score greater than or equal to 2. Alternatively: At the initial screening and beginning of Phase II, subjects must have a baseline score on the MADRS greater than or equal to 20 and YMRS of less than 12.

-- Duration of current episode greater than 8 weeks. The definition of an episode is demarcated by a period of greater than 2 months when the subject did not meet full criteria for the DSM-IV-TR definition of Major Depressive Episode. Maximum duration of current episode cannot exceed 5 years.

- Current or past history of lack of response to at least one adequate antidepressant trial, operationally defined using the Antidepressant Treatment History Form (ATHF); a failed adequate trial of ECT would count as an adequate antidepressant trial (unless the ECT occurred within the last year, in which case the participant will be excluded).

- If currently on a stable dose of antidepressant medication, the dosage has been unchanged for at least four weeks prior to study entry. The medication must be continued, and at the same dosage throughout study participation.

- Each subject must have a level of understanding sufficient to agree to all required tests and examinations and sign an informed consent document.

- All subjects must have undergone a screening assessment under protocol 01-M-0254, The Evaluation of Patients with Mood and Anxiety Disorders and Healthy Volunteers .

- Subjects are willing and able to adhere to the intensive treatment schedule and all required study visits.

EXCLUSION CRITERIA:

- Pregnant or nursing women or women who plan to become pregnant in the next 20 weeks while in the study.

Persons who are able to get pregnant must be willing to use at least one form of effective birth control

during the entire period of study participation (or until last clinical labs and rating) and have a negative pregnancy

test at screening.

- Current or recent (within the past 6 months) diagnosis of substance abuse or dependence (excluding nicotine and caffeine)

- Past or current history of tinnitus

- Non-native English language speaker

- History of seizure except those therapeutically induced by ECT (childhood febrile seizures are acceptable and these subjects may be included in the study), history of epilepsy in self or first degree relatives, stroke, brain surgery, participants with history of any head trauma within 6 months of screening, or beyond 6 months prior to screening, history of head trauma with evidence of traumatic abnormality appearing on their brain scan, or with loss of consciousness >5 min, or with other sequelae, excluding headache, lasting > 24 hours will not be included in the study.

- Diagnosed with the following conditions (current unless otherwise stated):

-- Any other current primary Axis I mood or psychotic disorder, including bipolar disorder, with the exception of most anxiety disorders (including generalized anxiety disorder (GAD), social anxiety disorder (also known as social phobia), specific phobia, panic disorder with and without agoraphobia, posttraumatic stress disorder (PTSD), anxiety secondary to medical condition, acute stress disorder (ASD), although with .obsessive-compulsive disorder (OCD) and substance-induced anxiety disorder excluded. While these anxiety disorders can be comorbid, they must be stable and the MDD must be the primary diagnosis.

-- Depression secondary to a general medical condition, or substance-induced.

-- Any bipolar disorder or psychotic disorder (lifetime), including schizoaffective disorder, or major depression with psychotic features in this or previous episodes.

-- Eating disorder (current or within the past year).

-- Obsessive compulsive disorder (lifetime).

-- ADHD (currently being treated).

-- Subjects meeting criteria for Axis II cluster A or B diagnosis based upon DSM-IV TR criteria, which in the judgment of the Investigator may hinder the subjects in completing the procedures required by the study protocol.

- Subjects currently engaged or planning to engage in other treatment during the course of Phases I and II of the study (including behavior therapy, or other types of individual, family, or group psychotherapy/counseling), or subjects planning to start an antidepressant medication during the course of Phases I and II.

- Increased risk of seizure for any reason, including prior diagnosis of increased intracranial pressure (such as after large infarctions or trauma), or currently taking medication that lowers the seizure threshold.

- Subjects with an unstable or serious medical or neurological disorder

- Presence of any medical illness likely to alter brain morphology and/or physiology (e.g., hypertension, diabetes) unless if controlled by medications

-Presence of any implants, prosthesis, or other permanent alteration of the body that, in the opinion of the investigator, would be unsafe with MRI or TMS or that would produce an artifact that would compromise the integrity of data.

- Subjects who have hearing loss that has been clinically evaluated and diagnosed

- Participants who are uncomfortable in small closed spaces (have claustrophobia), unable to lie comfortably supine for up to 90 minutes, and would feel uncomfortable in the MRI machine (for subjects doing imaging component of the study only).

- Subjects with any of the following treatment histories:

-- Lifetime history of TMS treatment.

-- Use of any investigational drug or device within 4 weeks of starting the study.

- Clinically significant abnormal lab tests

- Positive HIV test

- Subjects who, in the investigator s judgment, pose a current serious suicidal or homicidal risk.

- A current NIMH employee/staff or their immediate family member.

- A positive test for COVID-19 or symptoms consistent with COVID-19 infection

- Subjects who have allergies to lidocaine or previous adverse reaction to lidocaine.


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Citations:

Not Provided

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Contacts:

Principal Investigator

Referral Contact

For more information:

Sarah H. Lisanby, M.D.
National Institute of Mental Health (NIMH)
BG 6001 EXECUTIVE BLVD NSC RM 4129
6001 EXECUTIVE BLVD
ROCKVILLE MD 20852
(301) 339-4831
lisanbysh@mail.nih.gov

Ekaete C. Ekpo
National Institute of Mental Health (NIMH)
National Institutes of Health
Building 10
Room 2D39
10 Center Drive
Bethesda, Maryland 20892
(301) 827-1874
ekaete.ekpo@nih.gov

Office of Patient Recruitment
National Institutes of Health Clinical Center (CC)
Building 61, 10 Cloister Court
Bethesda, Maryland 20892
Toll Free: 1-800-411-1222
Local Phone: 301-451-4383
TTY: TTY Users Dial 7-1-1
ccopr@nih.gov

Clinical Trials Number:

NCT03289923

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